Book Review: Medical Device Use Error: Root Cause Analysis

In a simple but lucid manner, this book addresses medical device use error, utilizing root cause analysis as a structured method to examine serious adverse events. It is an excellent resource for human factors practitioners, medical device manufacturers and designers, clinicians at the bedside, biomedical engineers, caregivers at home, and students interested in understanding effective and safe design aspects of typical medical devices.

Wiklund et al. emphasize the term use error rather than user error or human error, often seen in the human factors literature, thus minimizing the blame on the user for adverse outcomes. Each of the book’s 14 chapters offers sidebars containing additional pertinent information, and there is a thorough compilation of resources at the end of the book. In addition to explaining the systems approach of the root cause analysis process in detail, the authors describe the relevance of the regulatory process and applicable standards for usability testing of a medical device.

The most significant part of the book is chapter 12, wherein more than 100 pages are devoted to describing a variety of examples of potential use errors arising from 30 products as well as suggesting ways to rectify these errors. With admirable visuals, each example is organized into product description, use error title, use error description, potential hazards resulting from these errors, root cause(s) with appropriate justifications, and proposed improvements. Given the extensive content in chapter 12, especially with the inclusion of exceptional mitigation strategies for each product, I think the authors should have added “and Action” to the book title, to reflect the ongoing efforts of the National Patient Safety Foundation in applying sustainable systems-based improvements.

Although the authors provide their preferred approach to detect root causes, it was good to see that their final chapter includes other root cause analysis methods used in the health care community. This last chapter also included the Joint Commission’s framework for conducting a root cause analysis and action plan, thus making readers aware of the mandatory requirements (at least in a majority of U.S. states) for conducting this root cause methodology either proactively or retrospectively to a sentinel event.

I wish the authors had concluded each chapter with a summary similar to the one provided in chapter 4. Overall, this is a well-written book that can be used as a quick reference guide by a variety of professionals who deal with medical devices at either home or work.